Universal reference book for medicines
Name of the drug: RECTODELT (RECTODELT)

Active substance: prednisolone

Type: GCS for topical application

Manufacturer: TROMMSDORFF GmbH & Co.KG Arzneimittel (Germany)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

Suppresses the function of white blood cells and tissue macrophages. Limits the migration of leukocytes to the area of ​​inflammation. Violates the ability of macrophages to phagocytosis, as well as to the formation of interleukin-1. Promotes the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of ​​inflammation. Reduces the permeability of capillaries due to the release of histamine. Suppresses the activity of fibroblasts and the formation of collagen.
Inhibits the activity of phospholipase A 2 , which leads to suppression of the synthesis of prostaglandins and leukotrienes.
Suppresses the release of COX (mainly COX-2), which also contributes to a decrease in the production of prostaglandins.
Reduces the number of circulating lymphocytes (T- and B-cells), monocytes, eosinophils and basophils due to their movement from the vascular bed into the lymphoid tissue;
suppresses the formation of antibodies.
Prednisolone suppresses pituitary release of ACTH and ОІ-lipotropin, but does not reduce the level of circulating О±-endorphin.
Oppresses the secretion of TSH and FSH.
With direct application on the vessels has a vasoconstrictor effect.

Prednisolone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats.
Stimulates gluconeogenesis, promotes the capture of amino acids by the liver and kidneys and increases the activity of gluconeogenesis enzymes. In the liver, prednisolone enhances the storage of glycogen, stimulating the activity of glycogen synthetase and the synthesis of glucose from protein metabolism products. Increasing the glucose level in the blood activates the release of insulin.
Prednisolone suppresses the capture of glucose by fat cells, which leads to activation of lipolysis.
However, due to an increase in the secretion of insulin, lipogenesis stimulates, which contributes to the accumulation of fat.
Has catabolic effect in lymphoid and connective tissue, muscles, fatty tissue, skin, bone tissue.
To a lesser extent than hydrocortisone, it affects the processes of water-electrolyte metabolism: it helps to eliminate the potassium and calcium ions, to delay the sodium and water ions in the body. Osteoporosis and Itenko-Cushing's syndrome are the main factors limiting long-term therapy to SCS. As a result of catabolic action, growth can be suppressed in children.
In high doses, prednisolone can increase the excitability of brain tissue and helps lower the threshold of convulsive readiness.
Stimulates excess production of hydrochloric acid and pepsin in the stomach, which leads to the development of peptic ulcers.
With systemic use, the therapeutic activity of prednisolone is due to anti-inflammatory, antiallergic, immunosuppressive and antiproliferative action.

With external and local application, the therapeutic activity of prednisolone is due to anti-inflammatory, anti-allergic and anti-exsudative (due to vasoconstrictor effect) action.

In comparison with hydrocortisone, the anti-inflammatory activity of prednisolone is 4 times higher, mineralocorticoid activity is 0.6 times less.

When ingested well absorbed from the digestive tract.
C max in plasma is observed after 90 minutes. In plasma, most of the prednisolone binds to transcortin (cortisol-binding globulin). Metabolized mainly in the liver.
T 1/2 is about 200 minutes.
It is excreted by the kidneys in unchanged form - 20%.
For oral and parenteral administration: rheumatism;
rheumatoid arthritis, dermatomyositis, nodular periarteritis, scleroderma, Bechterew's disease, bronchial asthma, asthmatic status, acute and chronic allergic diseases, anaphylactic shock, Addison's disease, acute adrenocortical insufficiency, adrenogenital syndrome; hepatitis, hepatic coma, hypoglycemic conditions, lipoid nephrosis; agranulocytosis, various forms of leukemia, lymphogranulomatosis, thrombocytopenic purpura, hemolytic anemia; chorea; pemphigus, eczema, pruritus, exfoliative dermatitis, psoriasis, pruritus, seborrheic dermatitis, SLE, erythroderma, alopecia.
For intraarticular administration: chronic polyarthritis, posttraumatic arthritis, osteoarthritis of large joints, rheumatic lesions of individual joints, arthrosis.

For infiltrative injection into tissues: epicondylitis, tendovaginitis, bursitis, humeropathy periarthritis, keloids, sciatica, Dupuytren's contracture, rheumatic and similar injuries to joints and various tissues.

For use in ophthalmology: allergic, chronic and atypical conjunctivitis and blepharitis;
inflammation of the cornea with intact mucosa; acute and chronic inflammation of the anterior segment of the choroid, sclera and episclera; sympathetic inflammation of the eyeball; after injuries and operations with prolonged irritation of eyeballs.
When administered orally for replacement therapy in adults, the initial dose is 20-30 mg / day, maintaining a dose of 5-10 mg / day.
If necessary, the initial dose may be 15-100 mg / day, supporting - 5-15 mg / day. The daily dose should be reduced gradually. For children, the initial dose is 1-2 mg / kg / day in 4-6 receptions, supporting - 300-600 mcg / kg / day.
With / m or / in the introduction of a dose, the multiplicity and duration of application are determined individually.

When intra-articular introduction to large joints, a dose of 25-50 mg is applied, for joints of medium size - 10-25 mg, for small joints - 5-10 mg.
For infiltration into tissues, depending on the severity of the disease and the magnitude of the affected area, doses of 5 to 50 mg are used.
Locally in ophthalmology apply 3 times / day, the course of treatment - no more than 14 days;
in dermatology - 1-3 times / day.
On the part of the endocrine system: menstrual disorders, oppression of the adrenal gland function, Itenko-Cushing syndrome, suppression of the hypophyseal-adrenal system, reduced tolerance to carbohydrates, steroid diabetes or manifestation of latent diabetes mellitus, growth retardation in children, delayed sexual development in children.

On the part of the digestive system: nausea, vomiting, steroid ulcer of the stomach and duodenum, pancreatitis, esophagitis, bleeding and perforation of the gastrointestinal tract, increase or decrease in appetite, flatulence, hiccough.
In rare cases - increased activity of hepatic transaminases and alkaline phosphatase.
On the part of metabolism: a negative nitrogen balance due to protein catabolism, increased excretion of calcium from the body, hypocalcemia, weight gain, increased sweating.

From the cardiovascular system: loss of potassium, hypokalemic alkalosis, arrhythmia, bradycardia (up to cardiac arrest);
steroid myopathy, heart failure (development or strengthening of symptoms), changes in ECG, characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.
From the musculoskeletal system: slowing growth and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological fractures, aseptic necrosis of the head of the humerus and thigh bone), muscle tendon rupture, muscle weakness, steroid myopathy, decrease muscle mass (atrophy).

From the side of the central nervous system: headache, increased intracranial pressure, delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor, cerebral seizures.

From the side of the organ of vision: a posterior subcapsular cataract, an increase in intraocular pressure (with possible damage to the optic nerve), trophic changes in the cornea, exophthalmos, a tendency to develop a secondary infection (bacterial, fungal, viral).

Dermatological reactions: petechiae, ecchymosis, thinning and fragility of the skin, hyper- or hypopigmentation, acne, striae, propensity to develop pyoderma and candidiasis.

Reactions caused by immunosuppressive action: slowing down regeneration processes, reducing resistance to infections.

When parenteral administration: in isolated cases, anaphylactic and allergic reactions, hyper- or hypopigmentation, atrophy of the skin and subcutaneous tissue, exacerbation after intrasynovial administration, arthropathy of the Charcot type, sterile abscesses, when injected into the foci on the head - blindness.

For short-term use according to vital indications - hypersensitivity to prednisolone.

For intraarticular administration and introduction directly into the lesion: previous arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intraarticular bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including in the anamnesis), as well as general infectious disease, expressed near-joint osteoporosis, absence of signs of inflammation in the joint ("dry" joint, for example, with osteoarthritis without synovitis), pronounced bone destruction
and joint deformity (sharp narrowing of the joint gap, ankylosis), joint instability as the outcome of arthritis, aseptic necrosis of the joints forming the epiphyses of bones.
For external use: bacterial, viral, fungal skin diseases, skin tuberculosis, skin manifestations of syphilis, skin tumors, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), childhood (up to 2 years, with itching in the anus - up to 12 years), rosacea, vulgar acne, perioral dermatitis.

For use in ophthalmology: bacterial, viral, fungal diseases of the eyes, tuberculosis of the eyes, trachoma, violation of the integrity of the ocular epithelium.

When pregnancy (especially in the first trimester) is used only for life indications.
If you need to use during lactation, you should carefully weigh the expected benefit of treatment for the mother and the risk to the child.
Use with caution in severe chronic renal failure.

Use with caution in severe chronic liver failure.

Children in the period of growth of GCS should be used only in absolute indications and under the close supervision of a doctor.

Contraindications for external use: children's age (up to 2 years, with itching in the anus - up to 12 years).

Use with caution in case of parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles, amebiasis, strongyloidiasis (established or suspected), systemic mycosis;
active and latent tuberculosis. The use in severe infectious diseases is permissible only against the background of specific therapy.
Use with caution 8 weeks before and 2 weeks after vaccination, with lymphadenitis after BCG vaccination, in immunodeficient conditions (including AIDS or HIV infection).

Use with caution in diseases of the digestive tract: peptic ulcer of stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with perforation or abscessing, diverticulitis.

With caution apply for diseases of the cardiovascular system, incl.
after a recent myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread the necrosis focus, slow the formation of scar tissue and, as a result, break the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia), endocrine diseases - diabetes including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itenko-Cushing's disease, with severe chronic renal and / or hepatic insufficiency, nephrourolythiasis, hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (grade III-IV), poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma.
If necessary, intraarticular administration should be used with caution in patients with a general severe condition, ineffectiveness (or short-term) of the effect of the previous 2 injections (taking into account the individual properties of the SCS used).

During treatment (especially long) it is necessary to observe the oculist, control AD ​​and water-electrolyte balance, as well as pictures of peripheral blood, glucose in the blood;
to reduce side effects, you can prescribe anabolic steroids, antibiotics, and also increase the intake of potassium in the body (diet, potassium preparations). It is recommended to clarify the need for the introduction of ACTH after a course of treatment with prednisolone (after a skin test!).
In Addison's disease, simultaneous use with barbiturates should be avoided.

After cessation of treatment, there may be a withdrawal syndrome, adrenal insufficiency, and an exacerbation of the disease, in connection with which prednisolone was prescribed.

With intercurrent infections, septic conditions and tuberculosis, simultaneous antibiotic therapy is necessary.

Children in the period of growth of GCS should be used only in absolute indications and under the close supervision of a doctor.

Outer should not be used for more than 14 days.
In case of application with common or pink acne, the disease may worsen.
With simultaneous application with salicylates, the probability of bleeding may increase.

With simultaneous use with diuretics, aggravation of electrolyte metabolism disorders is possible.

When used simultaneously with hypoglycemic drugs, the rate of lowering blood glucose decreases.

With simultaneous use with cardiac glycosides, the risk of developing glycosidic intoxication increases.

With simultaneous use with rifampicin, the therapeutic effect of rifampicin may be weakened.

With the simultaneous use of antihypertensive agents, it is possible to reduce their effectiveness.

With simultaneous application of coumarin derivatives, weakening of the anticoagulant effect is possible.

With the simultaneous use of rifampicin, phenytoin, barbiturates, the effect of prednisolone may be weakened.

With the simultaneous use of hormonal contraceptives - an increase in the action of prednisolone.

With the simultaneous use of acetylsalicylic acid, it is possible to reduce the content of salicylates in the blood.

With the simultaneous use of praziquantel, it is possible to reduce its concentration in the blood.

The emergence of hirsutism and acne is facilitated by the simultaneous use of other GCS, androgens, estrogens, oral contraceptives and steroid anabolics.
The risk of developing cataracts is increased when antipsychotic drugs, carbutamide and azathioprine are used against the background of GCS.
Simultaneous appointment with m-holinoblokatorami (including antihistamines, tricyclic antidepressants), nitrates contributes to the development of increased intraocular pressure.

[MSK] 01.04 in the RK is not registered.

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